Ocular Hypertension Clinical Trial
— DenaliOfficial title:
A Phase 3, Randomized, Multi-Regional, Double-Masked, Parallel-Group Trial Evaluating the Safety and Efficacy of NCX 470 0.1% vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)
| Verified date | February 2024 |
| Source | Nicox Ophthalmics, Inc. |
| Contact | Nicox Ophthalmics |
| Phone | 984-710-5354 |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in subjecs with ocular hypertension or open-angle glaucoma. Subjects will be randomized in a 1:1 ratio to NCX 470 0.1% or to latanoprost 0.005% to be administered to both eyes once daily in the evening for up to 12 months.
| Status | Recruiting |
| Enrollment | 670 |
| Est. completion date | September 2025 |
| Est. primary completion date | June 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 84 Years |
| Eligibility | Inclusion Criteria: - Diagnosis of open-angle glaucoma or ocular hypertension in both eyes - Qualifying IOP at 3 time points through the day at 2 visits following washout of IOP-lowering medication, if applicable - Qualifying best-corrected visual acuity in each eye - Ability to provide informed consent and follow study instructions Exclusion Criteria: - Narrow anterior chamber angles or disqualifying corneal thickness in either eye - Clinically significant ocular disease in either eye - Previous complicated surgery or certain types of glaucoma surgery in either eye - Incisional ocular surgery or severe trauma in either eye within the past 6 months - Uncontrolled systemic disease |
| Country | Name | City | State |
|---|---|---|---|
| China | Nicox Clinical Site | Beijing | |
| China | Nicox Clinical Site | Beijing | |
| China | Nicox Clinical Site | Changchun | Jilin |
| China | Nicox Clinical Site | Changsha | Hunan |
| China | Nicox Clinical Site | Changsha | Huna |
| China | Nicox Clinical Site | Chengdu | Sichuan |
| China | Nicox Clinical Site | Chongqing | |
| China | Nicox Clinical Site | Dalian | Liaoning |
| China | Nicox Clinical Site | Harbin | Heilongjiang |
| China | Nicox Clinical Site | Jinan | Shandong |
| China | Nicox Clinical Site | Lanzhou | Gansu |
| China | Nicox Clinical Site | Nanchang | Jiangxi |
| China | Nicox Clinical Site | Qingdao | Shandong |
| China | Nicox Clinical Site | Shanghai | |
| China | Nicox Clinical Site | Shanghai | |
| China | Nicox Clinical Site | Shanghai | |
| China | Nicox Clinical Site | Shantou | Guangdong |
| China | Nicox Clinical Site | Tianjing | |
| China | Nicox Clinical Site | Tianjing | |
| China | Nicox Clinical Site | Wenzhou | Xhejiang |
| China | Nicox Clinical Site | Wuhan | Hubei |
| China | Nicox Clinical Site | Xi'an | Shaanxi |
| China | Nicox Clinical Site | Yichang | Hubei |
| China | Nicox Clinical Site | Zhengzhou | Henan |
| China | Nicox Clinical Site | Zhengzhou | Henan |
| United States | Nicox Clinical Site | Asheville | North Carolina |
| United States | Nicox Clinical Site | Austin | Texas |
| United States | Nicox Clinical Site | Bangor | Maine |
| United States | Nicox Clinical Site | Bellevue | Washington |
| United States | Nicox Clinical Site | Boston | Massachusetts |
| United States | Nicox Clinical Site | Boynton Beach | Florida |
| United States | Nicox Clinical Site | Bronx | New York |
| United States | Nicox Clinical Site | Burbank | California |
| United States | Nicox Clinical Site | Chandler | Arizona |
| United States | Nicox Clinical Site | Chaska | Minnesota |
| United States | Nicox Clinical Site | Cincinnati | Ohio |
| United States | Nicox Clinical Site | Cincinnati | Ohio |
| United States | Nicox Clinical Site | Clifton Park | New York |
| United States | Nicox Clinical Site | Cranberry Township | Pennsylvania |
| United States | Nicox Clinical Site | Danbury | Connecticut |
| United States | Nicox Clinical Site | Delray Beach | Florida |
| United States | Nicox Clinical Site | Dothan | Alabama |
| United States | Nicox Clinical Site | El Paso | Texas |
| United States | Nicox Clinical Site | Eugene | Oregon |
| United States | Nicox Clinical Site | Falls Church | Virginia |
| United States | Nicox Clinical Site | Fargo | North Dakota |
| United States | Nicox Clinical Site | Fort Lauderdale | Florida |
| United States | Nicox Clinical Site | Fort Myers | Florida |
| United States | Nicox Clinical Site | Garden Grove | California |
| United States | Nicox Clinical Site | Grand Rapids | Michigan |
| United States | Nicox Clinical Site | Houston | Texas |
| United States | Nicox Clinical Site | Houston | Texas |
| United States | Nicox Clinical Site | Huntington Beach | California |
| United States | Nicox Clinical Site | Indianapolis | Indiana |
| United States | Nicox Clinical Site | Jacksonville | Florida |
| United States | Nicox Clinical Site | Jupiter | Florida |
| United States | Nicox Clinical Site | Kansas City | Missouri |
| United States | Nicox Clinical Site | Kingston | Pennsylvania |
| United States | Nicox Clinical Site | La Jolla | California |
| United States | Nicox Clinical Site | Lakeland | Florida |
| United States | Nicox Clinical Site | Lancaster | Massachusetts |
| United States | Nicox Clinical Site | Largo | Florida |
| United States | Nicox Clinical Site | Memphis | Tennessee |
| United States | Nicox Clinical Site | Memphis | Tennessee |
| United States | Nicox Clinical Site | Mission | Texas |
| United States | Nicox Clinical Site | Morrow | Georgia |
| United States | Nicox Clinical Site | Mount Dora | Florida |
| United States | Nicox Clinical Site | Murrieta | California |
| United States | Nicox Clinical Site | Newport Beach | California |
| United States | Nicox Clinical Site | Pasadena | California |
| United States | Nicox Clinical Site | Peoria | Illinois |
| United States | Nicox Clinical Site | Petaluma | California |
| United States | Nicox Clinical Site | Phoenix | Arizona |
| United States | Nicox Clinical Site | Redlands | California |
| United States | Nicox Clinical Site | Rock Island | Illinois |
| United States | Nicox Clinical Site | Roswell | Georgia |
| United States | Nicox Clinical Site | Saint George | Utah |
| United States | Nicox Clinical Site | Saint Louis | Missouri |
| United States | Nicox Clinical Site | San Antonio | Texas |
| United States | Nicox Clinical Site | San Antonio | Texas |
| United States | Nicox Clinical Site | San Antonio | Texas |
| United States | Nicox Clinical Site | San Francisco | California |
| United States | Nicox Clinical Site | Seattle | Washington |
| United States | Nicox Clinical Site | Seattle | Washington |
| United States | Nicox Clinical Site | Sugar Land | Texas |
| United States | Nicox Clinical Site | Troy | New York |
| United States | Nicox Clinical Site | Venice | Florida |
| United States | Nicox Clinical Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Nicox Ophthalmics, Inc. |
United States, China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline IOP | Mean IOP change from time-matched baseline at 8AM and 4PM time points at the Week 2, Week 6 and Month 3 Visits in the study eye | Up to 3 months | |
| Secondary | Change from baseline in diurnal IOP | Mean diurnal IOP change from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye | Up to 3 months | |
| Secondary | Frequency and incidence of treatment-emergent adverse events | Number and percentage of subjects with ocular and non-ocular treatment-emergent adverse events | 12 months | |
| Secondary | Rate of discontinuation | Percentage of subjects in each treatment group who discontinue study participation | 12 months |
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